2.1

Study design

DELIVER was a prospective, multicenter, single-arm, open-label registry. Patients were enrolled at 164 centers in 30 countries across Europe, Asia, the Middle East, and Latin America from January 2011 to May 2012. The primary objective of the study was to assess the deliverability of the R-ZES as a primary stent or as a secondary cross-over stent following delivery failure of another stent type in real-world patients. A post hoc comparison of radial and femoral approaches for device implantation was conducted and is presented in this article.

The study protocol was approved by local ethics committees where required and was conducted in accordance with the Declaration of Helsinki. Written informed consent was provided by all patients at the time of enrolment. Data were entered into a Web-based database (Oracle Clinical, Oracle Corp, Redwood City, CA). Source data for all patients with an adverse event were collected and reviewed for accuracy. Collected cardiac enzyme records were checked for otherwise unreported myocardial infarction (MI). Suspected MI events were referred to the clinical events committee for adjudication.

2.2

Patient population

Patients undergoing PCI and are suitable for treatment with the R-ZES as determined by the implanting physician were enrolled. Eligible patients had symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft stenoses that were amenable to percutaneous treatment.

The exclusion criteria included pregnancy; participating in another study that interfered with study outcomes; untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media; and contraindication to antiplatelet or anticoagulation therapy.

Patients were treated in accordance with the current practices of the participating centers.

Patients were determined prospectively as complex as having one or more of the following baseline characteristics: renal insufficiency (≥ 140 μmol/L), left ventricular ejection fraction < 30%, acute MI (≤ 72 h), > 1 lesion per vessel, ≥ 2 vessels stented, lesions > 27 mm, bifurcations, bypass grafts, in-stent restenosis, unprotected left main, lesions with thrombus, or total occlusion (preprocedure TIMI = 0).

Clinical data from all the enrolled patients were collected after the procedure and at discharge.

2.3

Study outcomes and definitions

The primary outcome of the study was delivery success when R-ZES was used as the primary stent. Secondary outcomes included device, lesion, and procedure success; in-hospital target lesion failure (TLF); in-hospital major adverse cardiac events (MACE); resource utilization; and acute deliverability parameters.

Delivery success was defined as complete passage of the stent across the target lesion with full expansion of the stent to the desired diameter at the desired location. Lesion success was defined as the attainment of less than 50% residual stenosis of the target lesion by any percutaneous method. Device success was defined as the attainment of less than 50% residual stenosis of the target lesion using only the R-ZES. Procedure success was defined as attainment of a less than 50% residual stenosis by any percutaneous method with no in-hospital MACE.

TLF was defined as cardiac death, target vessel myocardial infarction (TVMI; Q-wave and non-Q-wave), or clinically-indicated target lesion revascularization (TLR; percutaneous or surgical). MACE was defined as all-cause death, MI (Q-wave and non–Q-wave), emergent coronary artery bypass surgery, or clinically driven repeat TLR by percutaneous or surgical method. MI was defined using the extended historical criteria . Stent thrombosis was defined using Academic Research Consortium criteria . Deaths were considered cardiac unless a noncardiac cause could unequivocally be assigned.

All deaths and reports of suspected MI, revascularization, and stent thrombosis were adjudicated by an independent clinical events committee comprised of multiple cardiologists not involved in the study. Source documents—including angiograms—were collected and used for adjudication. The clinical events committee met regularly and was coordinated by the Harvard Clinical Research Institute (Boston, MA). Baseline lesion characteristics, however, were assessed by the operator.

2.4

Statistical analysis

Analyses were conducted on an intention to treat basis, and a patient was considered enrolled when a valid consent/data release form was obtained and the R-ZES was introduced into the guide catheter. Descriptive statistics for the baseline characteristics and clinical outcomes were provided. The subsets of radial and femoral approaches were compared. Categorical variables were reported as counts and percentages, and differences were assessed using Fisher’s exact test. Continuous variables were presented as mean ± standard deviation and were compared using a two-sample t-test.

The post-hoc comparison of clinical results based on radial and femoral approach was not prespecified and randomized, thus there were differences in baseline characteristics. To account for these differences comparisons of post-procedure details and in-hospital safety and effectiveness outcomes between radial and femoral approach were assessed using propensity scores. The propensity scores were calculated with radial access and femoral access as dependent variables, and the following baseline variables as independent variables: age, male sex, prior MI, prior coronary artery bypass graft, diabetes, insulin-dependent diabetes, history of hypertension, current cardiac status, left ventricular ejection fraction, renal insufficiency, vessel location, lesion type, lesion length, moderate/severe calcification, tortuosity ≥ 45°, bifurcation, trifurcation, thrombus, chronic total occlusion, preprocedure TIMI 0 to 2, preprocedure RVD (mm), preprocedure MLD (mm), and preprocedure diameter stenosis (%). Both p-values and adjusted p-values are reported.

Statistical analyses were conducted using SAS software 9.1 or later (SAS Institute, Cary, NC, USA). P values < 0.05 were considered statistically significant.

2.1

Study design

DELIVER was a prospective, multicenter, single-arm, open-label registry. Patients were enrolled at 164 centers in 30 countries across Europe, Asia, the Middle East, and Latin America from January 2011 to May 2012. The primary objective of the study was to assess the deliverability of the R-ZES as a primary stent or as a secondary cross-over stent following delivery failure of another stent type in real-world patients. A post hoc comparison of radial and femoral approaches for device implantation was conducted and is presented in this article.

The study protocol was approved by local ethics committees where required and was conducted in accordance with the Declaration of Helsinki. Written informed consent was provided by all patients at the time of enrolment. Data were entered into a Web-based database (Oracle Clinical, Oracle Corp, Redwood City, CA). Source data for all patients with an adverse event were collected and reviewed for accuracy. Collected cardiac enzyme records were checked for otherwise unreported myocardial infarction (MI). Suspected MI events were referred to the clinical events committee for adjudication.

2.2

Patient population

Patients undergoing PCI and are suitable for treatment with the R-ZES as determined by the implanting physician were enrolled. Eligible patients had symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft stenoses that were amenable to percutaneous treatment.

The exclusion criteria included pregnancy; participating in another study that interfered with study outcomes; untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media; and contraindication to antiplatelet or anticoagulation therapy.

Patients were treated in accordance with the current practices of the participating centers.

Patients were determined prospectively as complex as having one or more of the following baseline characteristics: renal insufficiency (≥ 140 μmol/L), left ventricular ejection fraction < 30%, acute MI (≤ 72 h), > 1 lesion per vessel, ≥ 2 vessels stented, lesions > 27 mm, bifurcations, bypass grafts, in-stent restenosis, unprotected left main, lesions with thrombus, or total occlusion (preprocedure TIMI = 0).

Clinical data from all the enrolled patients were collected after the procedure and at discharge.

2.3

Study outcomes and definitions

The primary outcome of the study was delivery success when R-ZES was used as the primary stent. Secondary outcomes included device, lesion, and procedure success; in-hospital target lesion failure (TLF); in-hospital major adverse cardiac events (MACE); resource utilization; and acute deliverability parameters.

Delivery success was defined as complete passage of the stent across the target lesion with full expansion of the stent to the desired diameter at the desired location. Lesion success was defined as the attainment of less than 50% residual stenosis of the target lesion by any percutaneous method. Device success was defined as the attainment of less than 50% residual stenosis of the target lesion using only the R-ZES. Procedure success was defined as attainment of a less than 50% residual stenosis by any percutaneous method with no in-hospital MACE.

TLF was defined as cardiac death, target vessel myocardial infarction (TVMI; Q-wave and non-Q-wave), or clinically-indicated target lesion revascularization (TLR; percutaneous or surgical). MACE was defined as all-cause death, MI (Q-wave and non–Q-wave), emergent coronary artery bypass surgery, or clinically driven repeat TLR by percutaneous or surgical method. MI was defined using the extended historical criteria . Stent thrombosis was defined using Academic Research Consortium criteria . Deaths were considered cardiac unless a noncardiac cause could unequivocally be assigned.

All deaths and reports of suspected MI, revascularization, and stent thrombosis were adjudicated by an independent clinical events committee comprised of multiple cardiologists not involved in the study. Source documents—including angiograms—were collected and used for adjudication. The clinical events committee met regularly and was coordinated by the Harvard Clinical Research Institute (Boston, MA). Baseline lesion characteristics, however, were assessed by the operator.

2.4

Statistical analysis

Analyses were conducted on an intention to treat basis, and a patient was considered enrolled when a valid consent/data release form was obtained and the R-ZES was introduced into the guide catheter. Descriptive statistics for the baseline characteristics and clinical outcomes were provided. The subsets of radial and femoral approaches were compared. Categorical variables were reported as counts and percentages, and differences were assessed using Fisher’s exact test. Continuous variables were presented as mean ± standard deviation and were compared using a two-sample t-test.

The post-hoc comparison of clinical results based on radial and femoral approach was not prespecified and randomized, thus there were differences in baseline characteristics. To account for these differences comparisons of post-procedure details and in-hospital safety and effectiveness outcomes between radial and femoral approach were assessed using propensity scores. The propensity scores were calculated with radial access and femoral access as dependent variables, and the following baseline variables as independent variables: age, male sex, prior MI, prior coronary artery bypass graft, diabetes, insulin-dependent diabetes, history of hypertension, current cardiac status, left ventricular ejection fraction, renal insufficiency, vessel location, lesion type, lesion length, moderate/severe calcification, tortuosity ≥ 45°, bifurcation, trifurcation, thrombus, chronic total occlusion, preprocedure TIMI 0 to 2, preprocedure RVD (mm), preprocedure MLD (mm), and preprocedure diameter stenosis (%). Both p-values and adjusted p-values are reported.

Statistical analyses were conducted using SAS software 9.1 or later (SAS Institute, Cary, NC, USA). P values < 0.05 were considered statistically significant.

3.1

Patient disposition and characteristics

A total of 7740 patients (n = 10449 lesions, 12165 stents) were enrolled. The mean age was 63.5 ± 11.2 years, 76% of patients were male, and 35% had diabetes ( Table 1 ). Most lesions (59%) were class B2/C, the mean total lesion length per patient was 26.7 ± 17.5 mm, 35% of lesions were moderately or severely calcified, and 17% were bifurcated ( Table 2 ). The approach was radial in 46% of patients (n = 3564), femoral in 53% (n = 4128), and brachial in 1% (n = 48). The choice of access site was site-dependent: 31% of sites conducted ≥ 80% of cases using radial approach while 34% of sites conducted ≥ 80% of cases using femoral approach. Statistically significant differences between patients implanted using the radial and femoral approaches were observed in age, sex, medical history, diabetes, cardiac status, left ventricular ejection fraction, and renal insufficiency ( Table 1 ).

Lesions treated by radial approach were less complex ( Table 2 ). Specifically, they were more likely to be de novo lesions and less likely to be in-stent restenosis lesions, moderate or severely calcified, bifurcated, trifurcated, thrombotic. Additionally, lesions treated by radial approach were less likely to be located in a chronic total occlusion, the lesion length was significantly shorter, and the number of lesions per patient was less. The preprocedure diameter stenosis was less, and the preprocedure RVD was larger in patients treated with radial vs. femoral approach. Additionally lesion location differed by approach; lesions by radial approach were less likely to be in a saphenous vein graft and more likely to be in the left anterior descending artery ( Table 2 ).

3.2

Delivery success

The rate of delivery success was 98.9% (10617/10733 stents, 95% CI 98.7% to 99.1%) when R-ZES was implanted as the primary stent. Delivery success was consistent across complex patient groups, including chronic total occlusions, 98.3% (770/783), small vessels, 98.5% (3334/3385), overlapping stents, 98.4% (2119/2154), bifurcations, 98.9% (1943/1964), STEMI, 98.8% (1256/1271), and in-stent restenosis, 98.7% (540/547).

Delivery, lesion, and device success were very high with no differences based on delivery approach ( Table 3 ). In most cases, delivery failure was due to inability to reach the target lesion or to pass completely across the target lesion. The mean diameter stenosis decreased from 82.09 ± 13.34% preprocedure to 1.88 ± 6.70% postprocedure (n = 10439 evaluable lesions).

Table 3

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